Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476541
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2007-05-21
Brief Title:
NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall objective is to improve the cure rate of children with newly diagnosed acute myeloid leukemia AML who undergo risk-adapted therapy
Stem cell transplantation SCT is reserved to high-risk patients defined by cytogenetics and response to chemotherapy The efficacy and toxicity of Gemtuzumab ozogamicin GO Mylotarg will be evaluated
Stem cell transplantation SCT is reserved to high-risk patients defined by cytogenetics and response to chemotherapy The efficacy and toxicity of Gemtuzumab ozogamicin GO Mylotarg will be evaluated
Detailed Description:
The overall objective is to improve the cure rate of pediatric patients with newly diagnosed acute myeloid leukemia AML The specific aims are as follows
11 Therapeutic aims
To improve the event-free survival EFS of AML patients who undergo risk-adapted therapy
To improve the overall survival OS by reserving stem cell transplantation SCT to high-risk patients based on cytogenetics and response to induction therapy
To compare the outcome of SCT using HLA-matched sibling donor MSD or HLA-matched unrelated donor MUD
To assess the efficacy and toxicity of Gemtuzumab ozogamicin GO Mylotarg as post consolidation therapy
12 Biologic aims
To study minimal residual disease MRD levels in blood and bone marrow BM at defined time points and to study the prognostic impact of MRD
To test in vitro cellular drug resistance at diagnosis and relapse and correlate these data to background factors and clinical outcome
To secure storage of biological material from diagnosis for future biologic studies
11 Therapeutic aims
To improve the event-free survival EFS of AML patients who undergo risk-adapted therapy
To improve the overall survival OS by reserving stem cell transplantation SCT to high-risk patients based on cytogenetics and response to induction therapy
To compare the outcome of SCT using HLA-matched sibling donor MSD or HLA-matched unrelated donor MUD
To assess the efficacy and toxicity of Gemtuzumab ozogamicin GO Mylotarg as post consolidation therapy
12 Biologic aims
To study minimal residual disease MRD levels in blood and bone marrow BM at defined time points and to study the prognostic impact of MRD
To test in vitro cellular drug resistance at diagnosis and relapse and correlate these data to background factors and clinical outcome
To secure storage of biological material from diagnosis for future biologic studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None